Iron Sucrose in Non-Dialysis Dependent (NDD-CKD) Pediatric Patients

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to assess the pharmacokinetics of Venofer (Iron Sucrose Injection) in NDD-CKD pediatric patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: American Regent, Inc.; Luitpold Pharmaceuticals
• Treatments: Ferric Oxide, Saccharated; Hematinics

Criteria

Inclusion Criteria:

• Age > or = 12 to < or = 16 years

• Parent and/or legal guardian able to give informed consent

• Subject able to give written assent for participating in the study

• NDD-CKD defined as: kidney damage for 3 months or longer, or GFR < 60 for 3 months or longer

• Hemoglobin indicative of anemia

• Ferritin indicative of iron deficiency anemia

• If appropriate, subject must be willing to use an accepted form of birth control from time of screening through the follow-up period

Exclusion Criteria:

• Known history of hypersensitivity to any component of Venofer

• Parenteral iron within 14 days of the screening visit

• Dialysis dependent-CKD

• Chronic or serious active infection

• Pregnancy or lactation

• Subjects with causes of iron deficiency anemia other than CKD

• Blood transfusion within the last month or anticipated during the study

• Body weight < 55 pounds

• Received an investigational drug within 30 days before screening